Cleared Traditional

K152061 - IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152061 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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Mar 2016
Decision
223d
Days
Class 2
Risk

K152061 is an FDA 510(k) clearance for the IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material. Classified as System, Test, Thyroid Autoantibody (product code JZO), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 3, 2016 after a review of 223 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5870 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K152061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2015
Decision Date March 03, 2016
Days to Decision 223 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 104d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZO System, Test, Thyroid Autoantibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.